Mylan Pharmaceuticals Inc. recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002
Recalled October 28, 2020 · FDA recall D-0049-2021 · Mylan Pharmaceuticals
Hazard
Out-of-specification organic impurity results obtained during routine stability testing. · FDA Class III
Units
10,695 bottles
Sold at
Nationwide within the United States
Description
Out-of-specification organic impurity results obtained during routine stability testing.
Product
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Manufacturer(s)
Mylan Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →